THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910

K071826 · Fox Hollow Technologies · QEZ · Nov 9, 2007 · Cardiovascular

Device Facts

• Record ID: K071826
• Device Name: THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910
• Applicant: Fox Hollow Technologies
• Product Code: QEZ · Cardiovascular
• Decision Date: Nov 9, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Rinspirator is intended to infuse physician specified fluid and remove/aspirate fluid, fresh, soft emboli and thrombi from the coronary and peripheral vasculature.

Device Story

The Rinspirator is a multi-lumen, rail-configuration embolectomy catheter system used to infuse fluids and aspirate fresh, soft emboli and thrombi from coronary and peripheral vasculature. The system comprises a catheter and a hand-held unit. The central lumen facilitates aspiration, while other lumens dispense infusible fluid. Used by physicians in clinical settings, the device aids in clearing vascular obstructions. The device is provided sterile for single-use. The primary modification from the predicate is the replacement of a silicone-based external coating with a hydrophilic coating (primer and topcoat) cured via UV light. The device functions similarly to the predicate, providing mechanical removal of thrombi to restore blood flow.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and material biocompatibility assessment per ISO-10993-1.

Technological Characteristics

Multi-lumen, rail-configuration catheter. Materials are biocompatible per ISO-10993-1. External surface features a hydrophilic coating (primer and topcoat in ethanol solvent base, UV-cured). Sterilized via Ethylene Oxide per ANSI/AAMI/ISO 11135 (SAL 10^-6).

Indications for Use

Indicated for patients requiring infusion of physician-specified fluids and aspiration of fluids, fresh, soft emboli, and thrombi from coronary and peripheral vasculature.

Regulatory Classification

Identification

An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

Predicate Devices

• Rinspiration Catheter System (K062275)

Submission Summary (Full Text)

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September 15, 2021

Fox Hollow Technologies Melissa Murphy 740 Bay Road Redwood City, California 94063

Re: K071826 Trade/Device Name: The Rinspirator Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA

Dear Melissa Murphy:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated November 9, 2007. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, [phone]. Gregory. Oconnell(@FDA.HHS.gov.

Sincerely,

Gregory W - Digitally signed by Gregory W. O'connell -S O'connell -S Date: 2021.09.15

Gregory O'Connell Assistant Director Plaque Modification Devices Team DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 9 2007

FoxHollow Technologies, Inc. c/o Ms. Melissa S. Murphy Regulatory Affairs Manager 740 Bay Road Redwood City, CA 94063

Re: K071826

Trade/Device Name: The Rinspirator Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: DXE Dated: October 17, 2007 Received: October 19, 2007

Dear Ms. Murphy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Melissa S. Murphy

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

er R. Vachner

NBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### 4. INDICATIONS FOR USE STATEMENT

510(k) Number if known: Kグアルマイ・

Device Name: The Rinspirator

The Rinspirator is intended to infuse physician specified fluid and remove/aspirate fluid, fresh, soft emboli and thrombi from the coronary and peripheral vasculature.

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (Per 21 CFR 807 Subpart C)

#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

sumai R. lochner

(Division Sign-Off) (Division Cardiovascular Devices

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510(k) wumber_6071826

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## 5. 510(K) SUMMARY

## 510(K) SUMMARY

| Device Name | The Rinspirator® | |
|------------------------|----------------------------------------------------|-------------|
| Classification Name: | Embolectomy Catheter<br>21 CFR §870.5150, Class II | NOV 09 2007 |
| Product Code: | DXE | |
| Common and Usual Name: | Embolectomy Catheter | |
| Proprietary Name: | The Rinspirator® | |

#### Predicate Device

The Rinspiration Catheter System (K062275), currently marketed by FoxHollow Technologies, Inc. (Redwood City, CA).

#### Summary

This summary of Special 510(k) safety and effectiveness is being submitted in accordance with requirements of SMDA 1990.

The Rinspirator is intended to infuse physician specified fluid and remove/aspirate fluid, fresh, soft emboli and thrombi from the coronary peripheral vasculature. The Rinspirator consists of a catheter and a hand-held unit with accessories. The Rinspirator Catheter is a multi-lumen, rail configuration catheter to dispense an infusible fluid. The central lumen of the catheter is used for aspiration. The Rinspirator is provided sterile for single-use. The system is sterilized by Ethylene Oxide (ANSI/AAMI/ISO 11135), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 106. The device is biocompatible per ISO-10993-1.

The only difference between the cleared Rinspiration Catheter System and The Rinspirator is the lubricious coating on the external surface of the catheter shaft. The previously cleared device is coated using a silicone based material, which is being replaced with a hydrophilic coating, consisting of a primer and topcoat in an ethanol solvent base, and is cured using UV light.

With the exception of the coating, The Rinspirator is substantially equivalent in materials of construction, design, intended use, and safety and efficacy to the predicate device. The subject device was shown to have substantially equivalent performance when compared to the predicate device. The Rinspirator with coating modifications is considered substantially equivalent to the Rinspiration Catheter System (K062275).

# Contact

Sridevi Sheshadri Clinical Research Associate FoxHollow Technologies, Inc. 740 Bay Road Redwood City, CA 94063 Main Tel [phone]

Date June 26, 2007